1. Field of the Invention
The disclosure of this application relates to a method and device for closing wounds or incisions without the use of invasive surgical procedures.
2. Background
The most common methods for closing wounds caused by lacerations or surgical incisions are suturing and stapling. Both of these procedures are skin invasive, which can traumatize and compromise the integrity of the wound. They increase the possibility of infection, expose the surgeon, as well as the patient to blood borne disease, leave behind scar tracks and require a follow-up visit for suture or staple removal.
As is well known, a cut that invades deeply into the tissue of the skin generally requires a mechanism for drawing the sides of a wound together to promote healing and to reduce the formation of scar tissue. Surgeons have become skilled in the various techniques of suturing to minimize the resulting blemish that occurs during the healing process. These methods have always generated issues of sterilization and the very nature of suturing requires a threshold of dexterity that escapes many care providers. This is particularly true in emergency situations, which call for immediate treatment to secure the wound for transport or until such time as proper surgery is available. Suturing, even by a skilled surgeon, punctures and stresses skin tissue causing scaring. It is well recognized that a sutureless wound closure would be a great benefit in many situations.
Beginning early in the 20th century, attempts were made to provide non-invasive closures. An early example of this is described in U.S. Pat. No. 1,074,413 (1913), which teaches the use of a pair of strips of fabric having adhesive backing. The strips of fabric are applied in parallel on either side of the wound and are constructed with threads extending transversely to bridge the wound. A compressive force is applied across the wound by tying opposing ends of the transverse threads of adjacent strips. In order to maintain the threads in an orderly fashion prior to use, another strip of fabric is attached to the distal ends of the threads to secure the thread ends in parallel for packaging and applying the closure. In one embodiment the threads are woven into both of the strips and then cut after placement of the strips on either side of the wound.
Another early device is described in U.S. Pat. No. 1,230,444 (1917). This is a woven fabric adhesive element having a gap intermittently formed in the length of the strip. The gap is formed in the weaving process by omitting weft strands (parallel to the length of the strip) in the gap and reducing the number of warp threads (transverse to the length of the strip) in the gap. A limited number of warp threads, therefore, bridge the gap. An advantage of this device is that it may be constructed in continuous lengths and packaged in a roll for convenient storage. A disadvantage is that the ability to apply a cross-wound force would be limited.
A more sophisticated approach is described in the reference Flynn, U.S. Pat. No. 2,196,296 (1940), in which a closure is designed for the express purpose of eliminating suturing. This device illustrates an early step in a trend towards interlocking multiple element devices. Dual adhesive strips are connected to a base adhesive element and to each other by threads woven through eyelets in the base element. The base element is applied to one side of the wound edge and one of the adhesive strips is applied to the other side. A cross wound force can be applied and held by drawing the threads through the eyes and pulling the remaining pair of adhesive strips away from the wound and attaching them to the skin beyond the associated counter part. The construction and assembly of this device is necessarily complex. It employs dual adhesive strips, i.e., the base strip and one of the adhesive strips applied in parallel on either side of the wound, but uses a third adhesive strip to generate and maintain the wound closing force.
U.S. Pat. No. 4,423,731 (1984) describes a suture-less wound closure which is similar to that shown in the above cited '413 patent. In this patent the distal ends of the bridging threads of one adhesive strip are interconnected by a further pulling strip which allows the bridging threads to be manipulated in concert. This configuration requires that the bridging threads or filaments of each of the adhesive strips be interlaced to enable the pulling strips to be pulled across the wound and secured. Dual adhesive strips are constructed with bridging filaments interlaced and attached to a pulling strip also having adhesive. The adhesive strips are applied on either side of the wound and are drawn together by grasping the pulling strips and thereby drawing the edges of the wound together. The closure is secured by adhering the pulling strip to the skin on the outer side of the opposing adhesive strip. Opposing forces can be applied simultaneously to each of the adhesive strips at the wound edge to close the wound.
The suture-less closure of U.S. Pat. No. 5,263,970 (1993) operates similarly to the closure of the '731 patent. It is however, formed of a single adhesive element which is placed over the wound. Centrally located over the wound opening, there are constructed dual sets of separated elongated extensions. The distal ends of each set of extensions are attached by a laterally extending tab portion. By manipulating the tabs, each set of extensions may be independently manipulated to allow the wound edges to be pulled together or otherwise advantageously moved. The closure is secured by adhering the tabs to adhesive pads on the exposed surface of the adhesive element.
An interlocked assembly of adhesive pads are assembled in the system of U.S. Pat. No. 5,534,010 (1996) to be operated in a manner similar to the '731 patent discussed above. First and second pads are adapted for application to the skin on either side of the wound. A third and fourth pad are adapted to adhere to the upper side of the first and second pads respectively. The third pad is attached by bridging filaments to the first pad and may be applied to the upper side of the second pad and the fourth pad is attached by bridging filaments to the second pad and may be applied to the upper side of the first pad.
In the bandage of U.S. Pat. No. 6,329,564 (2001), a two component interlocked system is devised which operates similarly to the system of the '010 patent. First and second adhesive strips are constructed with elongated connectors extending transverse to bridge the wound. The connectors are in turn interconnected by a pulling element. The adhesive strips, connectors, and pulling elements are interlaced so the connectors of one adhesive strip extend over the outer surface of the opposing adhesive strip. Similarly to the assembly discussed above opposing forces maybe applied to draw each of the adhesive strips toward each other and thereby close the wound.
All of the above bandage configurations, in particular the interlocked dual element style, appear to be difficult to manufacture and to use. The manipulation of a loose assembly of multiple parts in an emergency and possibly life-threatening situation is a challenging undertaking. It is a purpose of this invention to provide a suture-less wound closure which is more easily manufactured and packaged. It is another purpose of this invention to provide a wound closure which is easy to unpackage and apply.
The above cited prior art is consistent in several respects, namely, that two adhesive strips need to be provided for application to either side of the wound and that a mechanism is needed to apply forces to each of the adhesive strips to draw them together to close the wound. The prior art seems to solve this need by proposing multiple interlaced parts.
It is a purpose of this invention to construct a suture-less wound closing device in one piece that can be used on both sides of a wound without the need for interlacing the parts during manufacture. It is a purpose of this invention to provide a single element wound closure that does not require suturing, stapling or gluing.
A simple one piece closure is historically represented by the STERI-STRIP® adhesive strip available from 3M Corporation or butterfly shaped adhesive strips both of which are used to bridge the wound. These configurations may be used singly, in pairs, or multiple units to apply a closing force to the wound. A more complex version of such wound closures is shown in U.S. Patent Application, Pub. No. 2002/0099315, which was published Jul. 25, 2002. A substantially more complex version of this type of closure is described in U.S. Pat. No. 6,293,281 (2001).
A purpose of this invention is to simplify, improve upon, and facilitate the customization capability of these various adhesive strips, wound closure devices and methods. A purpose is to provide a simplified elemental device capable of applying a series of adhesive bandage strips that can be used to close wounds and can be adapted to a variety of surgical needs, incision sizes, and types of wounds. It is a further purpose of this invention to provide a closure that does not require any particular dexterity, skill, or knowledge and is reasonable in cost so that it can be used by anyone.
In the course of describing this invention below, the bottom of the closing device of this invention will refer to the surface that is intended to engage the skin and the upper side or top will refer to the side of a component that is facing away from the skin after application. Directions will be indicated according to the position of the wound being treated, for example, transverse shall refer to directions across the wound. The inner edge of the closing device shall refer to the side which is intended to be adjacent to the wound lip and the outer edge shall refer to the side of the device that is intended to be away from the wound.